A Revolution in HIV/AIDS Treatment
By German Velasquez
On September 25, 2025, two voluntary licensing agreements were announced between Gilead, the patent holder, and generic drug manufacturers in India for the supply of generic lenacapavir at $40 (instead of the original $28,218) per patient per year. However, too many countries are excluded from the agreements.
The negotiations on the Pathogen Access and Benefit Sharing System under the WHO Pandemic Agreement: State of Play as of September 2025
By Viviana Munoz Tellez, German Velasquez
The World Health Organization (WHO) Member States adopted a Pandemic Agreement in May 2025 but deferred negotiations on the critical Pathogen Access and Benefit Sharing System (PABS). Despite the tight timeline, the Intergovernmental Working Group (IGWG) has made minimal progress as of September 2025, with no draft text produced and formal negotiations yet to begin. The PABS system is essential for pandemic equity, balancing rapid pathogen sharing with equitable access to vaccines and treatments. But with the current approach to the IGWG process, without formal negotiations underway, Member States risk failing to finalize the PABS Annex by the March 2026 deadline.
New Amendments to the International Health Regulations: Strengthening Access to Health Products in Emergencies and Pandemics
By Viviana Munoz Tellez
The International Health Regulations amendments entered into force on September 19, 2025 across most World Health Organization (WHO) Member States. These updates don’t give WHO any new powers but help countries work better together to advance fair and timely access to health products such as vaccines, treatments and diagnostics needed to respond to health emergencies. The real challenge now is implementation and building the necessary capabilities to make these improvements function.
The Importance of Balanced Intellectual Property Systems for Patients’ Access to Medicines: An Analysis
By Archana Jatkar and Nicolás Tascón
Access to safe, effective, cost-effective, and quality-assured medicines is fundamental from a patients’ perspective. The International Generic and Biosimilar Medicines Association (IGBA) recently released a report highlighting the critical balance between innovation, competition, and timely access to medicines. This article delves into the key findings of IGBA’s report, their implications on patient access to medicines and national healthcare budgets, and the IGBA’s recommendations for improving the global pharmaceutical landscape.
Upholding health equity:
Access to medical products and reproductive rights
Side Event to the 59th Session of the Human Rights Council
23 June 2025
12:00 to 13:00
Room XXVII, Palais de Nations, Geneva, Switzerland
The pursuit of health equity, encompassing fair and just opportunities for all to achieve their full health potential, remains a paramount global challenge. The right to health is a fundamental part of our human rights and of our understanding of a life in dignity. This event will explore the indivisible links between equitable access to medical products, the advancement of sexual and reproductive health and rights (SRHR), and the strengthening of international cooperation as pillars for upholding this fundamental right for everyone, everywhere. The interconnectedness of these themes is central; they are not disparate issues but integral components of a holistic approach necessary to realise comprehensive health equity.
The side event is anticipated to significantly enhance participants’ understanding of the complex, intersecting challenges and opportunities in upholding health equity, particularly through improved access to medical products and the full realization of SRHR. The discussions aim to identify potential policy pathways, innovative approaches, and actionable strategies for key stakeholders to address existing inequities. Furthermore, a crucial outcome will be a reinforced commitment to multilateralism and collaborative action as essential tools for tackling global health challenges and advancing the right to health, with the dialogue contributing valuable insights to ongoing policy debates in relevant international fora, especially concerning the implementation of recent global agreements and agendas, while also strengthening networks and partnerships dedicated to health equity and human rights.
Scope of Compulsory License and Government Use of Patented Medicines
To meet public health needs governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines. These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted.
This table provides information of instances of their use.
Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
Submission by the South Centre to the Office of the United Nations High Commissioner for Human Rights on Inputs for the comprehensive report on ensuring access to medicines, vaccines and other health products (HRC resolution 50/13)
January 2025
The South Centre has provided input for the OHCHR report on new developments and challenges in ensuring access to medicines, vaccines and other health products.
Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
Los retos de futuras pandemias
Entre la política y la ciencia
¿Hacia dónde va la salud mundial?
Descripción:
Las nuevas pandemias son inevitables. ¿Cómo podemos estar mejor preparados para ellas y, sobre todo, cómo podemos evitar los errores e injusticias cometidos durante la pandemia de COVID19? Actualmente se están llevando a cabo negociaciones para formular un tratado internacional vinculante sobre prevención y preparación que garantice respuestas más justas a futuras pandemias. Este libro pretende ser una contribución crítica a estos debates en curso.
¿Cómo garantizar un acceso equitativo a los medicamentos y diagnósticos cuando la mayoría de ellos se producen en un número reducido de países? ¿Cómo explicar que la financiación actual de la cooperación sanitaria esté en manos de un pequeño grupo de países y fundaciones del Norte? ¿Cómo reforzar el papel de la Organización Mundial de la Salud, que actualmente desempeña un papel secundario en la coordinación de las políticas de salud pública? ¿Por qué se ha sustituido el concepto de «medicamentos esenciales», gran avance de la política de salud pública, por el de «contramedidas médicas», término más acorde con el afán de lucro del sector privado?
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
Les défis des futures pandémies
Enjeux politiques et négociations internationales
Details:
De nouvelles pandémies sont inéluctables. Comment mieux s’y préparer et surtout comment éviter les erreurs et injustices commises durant la pandémie du Covid-19 ? Des négociations sont en cours pour formuler un traité international contraignant sur la prévention et la préparation pour des réponses plus justes aux futures pandémies. Ce livre se veut une contribution critique aux débats en cours.
Comment garantir l’accès équitable aux médicaments et diagnostics, alors que la majorité d’entre eux sont produits dans un petit nombre de pays ? Comment expliquer que le financement actuel de la coopération en matière de santé se retrouve entre les mains d’un groupe réduit de pays et fondations du Nord ? Comment renforcer le rôle de l’Organisation mondiale de la santé, qui ne joue plus qu’un rôle mineur dans la coordination des politiques de santé publique ? Comment se fait-il que le concept de « médicaments essentiels », une avancée majeure dans les politiques de santé publique, soit remplacé par celui de « contre-mesures médicales », un terme qui s’accorde plutôt à la logique de profit du secteur privé ?
La préparation aux futures pandémies nous oblige à nous interroger : comment préserver l’intérêt général, la défense des droits de l’homme et la santé publique ?
Auteur: Germán Velásquez est conseiller spécial en matière de politique et de santé au South Centre à Genève.
Equity and Pandemic Preparedness: Navigating the 2024 Amendments to the International Health Regulations
By Nirmalya Syam
The amendments to the International Health Regulations (2005) (IHR) agreed upon in May 2024 are important for strengthening global health emergency preparedness and response. The negotiations resulted in the IHR amendment now recognizing the importance of equity, including equitable access to health products, enhancing IHR core capacities, and mobilizing financing. The amendments note the role of the World Health Organization (WHO) in facilitating timely access to necessary health products by removing barriers and supporting local production and distribution. However, the WHO authority to effectively act in those areas is limited. The IHR as amended will establish a Coordinating Financial Mechanism to provide predictable and sustainable financing for its implementation, particularly in developing countries.
Despite some advancements, the amendments fall short of imposing concrete obligations on developed countries to facilitate timely access to health products and financial support and transfer of technology to developing countries. Overall, the amended IHR represent a significant step toward a more equitable global health framework, setting a precedent for future international health instruments, including the proposed pandemic treaty.
